GRAIL, Inc. GRAL
GRAIL, Inc. (Nasdaq: GRAL) is an oncology diagnostics company.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Galleri | multi-cancer early detection | unclear | NA_NON_THERAPEUTIC |
Recent results and decisions
- Feb 19, 2026missed Randomized NHS-Galleri trial (142,000 participants) did not meet its primary endpoint of a statistically significant reduction in Stage III-IV cancers, though Stage IV diagnoses fell by more than 20% in rounds two and three and cancer detection rate rose four-fold.
The primary endpoint of statistically significant Stage III-IV reduction was not observed.
Filing - Feb 19, 2026positive Analysis of the full 35,000-participant PATHFINDER 2 study showed performance consistent with the earlier 25,000-participant analysis and a strong safety profile.
Completed analysis of the full 35,000 participant PATHFINDER 2 study, demonstrating performance consistent with the 25,000 patient analysis presented in October and a strong safety profile.
Filing - Jan 1, 2026submitted GRAIL completed submission of the final module of the Galleri PMA application to FDA in January 2026.
Completed submission of the final module of the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Galleri in January.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
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The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.